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42 U.S.C. § 247d–7fCollaboration and coordination

submitted 82 years ago by Pub. L. 109-417 to r/title-42-THE-PUBLIC-HEALTH-AND-WELFARE · 1,522 words · no verdicts yet

in plain englishAI-generated · not legal advice

This section lets the Secretary hold meetings between companies developing countermeasures without violating antitrust law, under strict rules. The Attorney General can approve written agreements from those meetings for a limited exemption. This antitrust protection ends after December 31, 2026.

(a) Limited antitrust exemption: (1) Meetings and consultations: (A) Authority: The Secretary, working with the Attorney General and Secretary of Homeland Security, may hold meetings or consultations with people developing security countermeasures, qualified countermeasures, or qualified pandemic/epidemic products, to discuss developing, making, distributing, buying, or storing them. The Secretary can call a meeting on request from Homeland Security, the Attorney General, the FTC Chairman, or any interested person, or on the Secretary's own initiative. The Secretary must give advance notice of the meeting and its topics to the Attorney General, the Chairman, and Homeland Security. (B) Conditions: Each meeting must be chaired (or, for a consultation, facilitated) by the Secretary; open to people involved in developing, making, distributing, buying, or storing the countermeasure, as the Secretary decides; open to the Attorney General, Homeland Security, and the Chairman; limited to discussing "covered activities" (defined below); and run so that no national-security or confidential business information leaks outside the meeting. (C) Limitation: The Secretary cannot force participants to reveal confidential business information. (D) Transcript: The Secretary must keep a complete word-for-word transcript of each meeting. That transcript can be withheld from public disclosure if the Secretary, with the Attorney General and Homeland Security, decides releasing it would threaten national security. (E) Exemption: It is not an antitrust violation to take part in a meeting held under these rules — but this protection does not cover any resulting agreement or conduct that isn't separately exempted under paragraph (4). (2) Submission of written agreements: The Secretary must send any written agreement from these meetings to the Attorney General and the Chairman, along with an explanation of its purpose, a description of its substance and methods, why cooperation is necessary, and any other information the Attorney General wants. (3) Exemption for conduct under approved agreement: Acting under an agreement that's been granted an exemption is not an antitrust violation, for as long as the exemption lasts. (4) Action on written agreements: Within 15 business days of getting a request, the Attorney General (with the Chairman) must grant, deny, partly grant, or propose changes to the exemption, in writing to the Secretary. An approved exemption starts immediately. The Attorney General can extend the 15-day deadline by up to 10 more business days. The Attorney General can only grant an exemption if satisfied the conduct won't cause serious anticompetitive harm beyond what's reasonably needed to make sure the countermeasure or product is available. (5) Limitation on and renewal of exemptions: An exemption only covers "covered activities" and must be renewed after 3 years (with any needed changes), unless the Attorney General decides against renewal using the same standard as before. (6) Authority to obtain information: Reviewing a request to grant or renew an exemption counts as an antitrust investigation under the Antitrust Civil Process Act. (7) Limitation on parties: Using information gained under an exempted agreement for any purpose beyond what the exemption allows brings back full antitrust and other legal liability. (8) Report: Starting one year after enactment and every two years after, the Attorney General and the Chairman must report to Congress on how this antitrust exemption has been used. (b) Sunset: This whole section stops applying after December 31, 2026. (c) Definitions: (1) "Antitrust laws" means the laws defined in section 12 of title 15, plus section 45 of title 15 where it covers unfair competition methods, plus any similar state law. (2) "Countermeasure or product" means a security countermeasure, qualified countermeasure, or qualified pandemic/epidemic product, as defined in subsection (a)(1). (3) "Covered activities" generally means any activity related to developing, making, distributing, buying, or storing a countermeasure or product — but it does NOT include, between two or more people: (i) exchanging competitor cost, profit, or distribution information not reasonably needed for the exempted activity; (ii) agreeing to restrict or require licensing/sharing of things not developed through the covered activity, or restricting a participant's other research unless needed to prevent misuse of shared proprietary information; (iii) agreeing to divide up a market with a competitor beyond what's exempted; (iv) exchanging competitor production information not reasonably needed for the covered activity; (v) agreeing to restrict or require production beyond what's exempted; (vi) restricting a participant's unrelated unilateral or joint activities; or (vii) agreeing to restrict or set the sale price of a countermeasure or product.
the actual law source: uscode.house.gov ↗public domain
(a) Limited antitrust exemption
(1) Meetings and consultations to discuss security countermeasures, qualified countermeasures, or qualified pandemic or epidemic product development
(A) Authority to conduct meetings and consultations

The Secretary, in coordination with the Attorney General and the Secretary of Homeland Security, may conduct meetings and consultations with persons engaged in the development of a security countermeasure (as defined in section 247d–6b of this title), a qualified countermeasure (as defined in section 247d–6a of this title), or a qualified pandemic or epidemic product (as defined in section 247d–6d of this title) for the purpose of the development, manufacture, distribution, purchase, or storage of a countermeasure or product. The Secretary may convene such meeting or consultation at the request of the Secretary of Homeland Security, the Attorney General, the Chairman of the Federal Trade Commission (referred to in this section as the “Chairman”), or any interested person, or upon initiation by the Secretary. The Secretary shall give prior notice of any such meeting or consultation, and the topics to be discussed, to the Attorney General, the Chairman, and the Secretary of Homeland Security.

(B) Meeting and consultation conditions

A meeting or consultation conducted under subparagraph (A) shall—

(i)

be chaired or, in the case of a consultation, facilitated by the Secretary;

(ii)

be open to persons involved in the development, manufacture, distribution, purchase, or storage of a countermeasure or product, as determined by the Secretary;

(iii)

be open to the Attorney General, the Secretary of Homeland Security, and the Chairman;

(iv)

be limited to discussions involving covered activities; and

(v)

be conducted in such manner as to ensure that no national security, confidential commercial, or proprietary information is disclosed outside the meeting or consultation.

(C) Limitation

The Secretary may not require participants to disclose confidential commercial or proprietary information.

(D) Transcript

The Secretary shall maintain a complete verbatim transcript of each meeting or consultation conducted under this subsection. Such transcript (or a portion thereof) shall not be disclosed under section 552 of title 5 to the extent that the Secretary, in consultation with the Attorney General and the Secretary of Homeland Security, determines that disclosure of such transcript (or portion thereof) would pose a threat to national security. The transcript (or portion thereof) with respect to which the Secretary has made such a determination shall be deemed to be information described in subsection (b)(3) of such section 552.

(E) Exemption
(i) In general

Subject to clause (ii), it shall not be a violation of the antitrust laws for any person to participate in a meeting or consultation conducted in accordance with this paragraph.

(ii) Limitation

Clause (i) shall not apply to any agreement or conduct that results from a meeting or consultation and that is not covered by an exemption granted under paragraph (4).

(2) Submission of written agreements

The Secretary shall submit each written agreement regarding covered activities that is made pursuant to meetings or consultations conducted under paragraph (1) to the Attorney General and the Chairman for consideration. In addition to the proposed agreement itself, any submission shall include—

(A)

an explanation of the intended purpose of the agreement;

(B)

a specific statement of the substance of the agreement;

(C)

a description of the methods that will be utilized to achieve the objectives of the agreement;

(D)

an explanation of the necessity for a cooperative effort among the particular participating persons to achieve the objectives of the agreement; and

(E)

any other relevant information determined necessary by the Attorney General, in consultation with the Chairman and the Secretary.

(3) Exemption for conduct under approved agreement

It shall not be a violation of the antitrust laws for a person to engage in conduct in accordance with a written agreement to the extent that such agreement has been granted an exemption under paragraph (4), during the period for which the exemption is in effect.

(4) Action on written agreements
(A) In general

The Attorney General, in consultation with the Chairman, shall grant, deny, grant in part and deny in part, or propose modifications to an exemption request regarding a written agreement submitted under paragraph (2), in a written statement to the Secretary, within 15 business days of the receipt of such request. An exemption granted under this paragraph shall take effect immediately.

(B) Extension

The Attorney General may extend the 15-day period referred to in subparagraph (A) for an additional period of not to exceed 10 business days.

(C) Determination

An exemption shall be granted regarding a written agreement submitted in accordance with paragraph (2) only to the extent that the Attorney General, in consultation with the Chairman and the Secretary, finds that the conduct that will be exempted will not have any substantial anticompetitive effect that is not reasonably necessary for ensuring the availability of the countermeasure or product involved.

(5) Limitation on and renewal of exemptions

An exemption granted under paragraph (4) shall be limited to covered activities, and such exemption shall be renewed (with modifications, as appropriate, consistent with the finding described in paragraph (4)(C)), on the date that is 3 years after the date on which the exemption is granted unless the Attorney General in consultation with the Chairman determines that the exemption should not be renewed (with modifications, as appropriate) considering the factors described in paragraph (4).

(6) Authority to obtain information

Consideration by the Attorney General for granting or renewing an exemption submitted under this section shall be considered an antitrust investigation for purposes of the Antitrust Civil Process Act (15 U.S.C. 1311 et seq.).

(7) Limitation on parties

The use of any information acquired under an agreement for which an exemption has been granted under paragraph (4), for any purpose other than specified in the exemption, shall be subject to the antitrust laws and any other applicable laws.

(8) Report

Not later than one year after the date of enactment of this Act 1 and biannually thereafter, the Attorney General and the Chairman shall report to Congress on the use of the exemption from the antitrust laws provided by this subsection.

(b) Sunset

The applicability of this section shall expire after December 31, 2026.

(c) Definitions

In this section:

(1) Antitrust laws

The term “antitrust laws”—

(A)

has the meaning given such term in subsection (a) of section 12 of title 15, except that such term includes section 45 of title 15 to the extent such section 45 of title 15 applies to unfair methods of competition; and

(B)

includes any State law similar to the laws referred to in subparagraph (A).

(2) Countermeasure or product

The term “countermeasure or product” refers to a security countermeasure, qualified countermeasure, or qualified pandemic or epidemic product (as those terms are defined in subsection (a)(1)).

(3) Covered activities
(A) In general

Except as provided in subparagraph (B), the term “covered activities” includes any activity relating to the development, manufacture, distribution, purchase, or storage of a countermeasure or product.

(B) Exception

The term “covered activities” shall not include, with respect to a meeting or consultation conducted under subsection (a)(1) or an agreement for which an exemption has been granted under subsection (a)(4), the following activities involving 2 or more persons:

(i)

Exchanging information among competitors relating to costs, profitability, or distribution of any product, process, or service if such information is not reasonably necessary to carry out covered activities—

(I)

with respect to a countermeasure or product regarding which such meeting or consultation is being conducted; or

(II)

that are described in the agreement as exempted.

(ii)

Entering into any agreement or engaging in any other conduct—

(I)

to restrict or require the sale, licensing, or sharing of inventions, developments, products, processes, or services not developed through, produced by, or distributed or sold through such covered activities; or

(II)

to restrict or require participation, by any person participating in such covered activities, in other research and development activities, except as reasonably necessary to prevent the misappropriation of proprietary information contributed by any person participating in such covered activities or of the results of such covered activities.

(iii)

Entering into any agreement or engaging in any other conduct allocating a market with a competitor that is not expressly exempted from the antitrust laws under subsection (a)(4).

(iv)

Exchanging information among competitors relating to production (other than production by such covered activities) of a product, process, or service if such information is not reasonably necessary to carry out such covered activities.

(v)

Entering into any agreement or engaging in any other conduct restricting, requiring, or otherwise involving the production of a product, process, or service that is not expressly exempted from the antitrust laws under subsection (a)(4).

(vi)

Except as otherwise provided in this subsection, entering into any agreement or engaging in any other conduct to restrict or require participation by any person participating in such covered activities, in any unilateral or joint activity that is not reasonably necessary to carry out such covered activities.

(vii)

Entering into any agreement or engaging in any other conduct restricting or setting the price at which a countermeasure or product is offered for sale, whether by bid or otherwise.

Source credit: (July 1, 1944, ch. 373, title III, § 319L–1, formerly Pub. L. 109–417, title IV, § 405, Dec. 19, 2006, 120 Stat. 2875, as amended Pub. L. 113–5, § 402(e)(1), Mar. 13, 2013, 127 Stat. 195; renumbered § 319L–1 of act July 1, 1944, and amended Pub. L. 116–22, title VII, § 701(e)(1), June 24, 2019, 133 Stat. 961; Pub. L. 118–22, div. B, title II, § 203(c), Nov. 17, 2023, 137 Stat. 120; Pub. L. 118–35, div. B, title I, § 103(c), Jan. 19, 2024, 138 Stat. 5; Pub. L. 118–42, div. G, title I, § 103(c), Mar. 9, 2024, 138 Stat. 398; Pub. L. 118–158, div. C, title I, § 3103(c), Dec. 21, 2024, 138 Stat. 1763; Pub. L. 119–4, div. B, title I, § 2103(c), Mar. 15, 2025, 139 Stat. 41; Pub. L. 119–37, div. F, title I, § 6103(c), Nov. 12, 2025, 139 Stat. 630; Pub. L. 119–75, div. J, title IV, § 6403(c), Feb. 3, 2026, 140 Stat. 688.)

history & why it existsrecord from the source credit
  • 1944Enacted · Pub. L. 109-417 · 120 Stat. 2875
  • 1944Amended · Pub. L. 116-22 · 133 Stat. 961
  • 2023Amended · Pub. L. 118-22 · 137 Stat. 120
  • 2024Amended · Pub. L. 118-35 · 138 Stat. 5
  • 2024Amended · Pub. L. 118-42 · 138 Stat. 398
  • 2024Amended · Pub. L. 118-158 · 138 Stat. 1763
  • 2025Amended · Pub. L. 119-4 · 139 Stat. 41
  • 2025Amended · Pub. L. 119-37 · 139 Stat. 630
  • 2026Amended · Pub. L. 119-75 · 140 Stat. 688

A history note hasn’t been published yet. The record shows enactment by Pub. L. 109-417 on 1944-07-01.

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